Catalog Number

AS79264

Brand Name

Focal 44 Sublative iD, (100 Pulse,Red)

Version/Model Number

AS79264

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090025,K090025

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

adda7d40-c376-4e27-9ebf-531547762960

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

37290109950717

Quantity per Package

10

Contains DI Package

07290109950716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-